IAVI and VaxDesign Partner to Develop an AIDS Vaccine Clinical Trial in a Test Tube

NEW YORK, March 3, 2008 — The International AIDS Vaccine Initiative (IAVI) today announced the first award from its Innovation Fund, a new funding mechanism that will identify and advance potential breakthrough technologies and apply them in the AIDS vaccine research field. This initial project will apply an exciting new technology, a simulated human immune system the size of a small coin, which has the potential to predict human immune responses to new vaccines and drugs.

Under development by VaxDesign Corporation, the Modular IMmune In vitro Construct (MIMIC™) system could radically transform AIDS vaccine research and development. The technology uses human immune cells from volunteers to create simulated human immune responses. The MIMIC models reproduce both innate and adaptive immune responses, and exhibit both humoral and cellular immunity. VaxDesign has the capacity to run thousands of these immune simulations per month. IAVI will first test the technology on licensed vaccines for yellow fever and rabies to see whether the immune responses generated in vitro are the same as those elicited in humans who receive the vaccine. If the technology proves successful, IAVI and VaxDesign will further develop and apply it to the screening of novel immunogens for AIDS vaccines at its AIDS Vaccine Development Laboratory in Brooklyn, New York.

“Currently, pre-clinical testing of AIDS vaccines is a labor-intensive, lengthy and expensive process. We hope this pioneering technology will enable us to rapidly test AIDS vaccine candidates and predict their effectiveness in humans in a way that has never before been possible with animal models,” said Dr. Wayne Koff, IAVI’s Senior Vice President for Research and Development. “What’s more, by collecting immune cells from different donors, promising vaccine candidates can be tested in diverse populations before they enter human testing.”

“HIV is a formidable adversary, and evaluating AIDS vaccine candidates will be the ultimate test for our MIMIC technology. We are excited to partner with IAVI to help develop the next generation of AIDS vaccine candidates,” said Dr. William Warren, President and CEO of VaxDesign.

Targeted primarily to small- and medium-sized biotechnology companies, IAVI’s Innovation Fund will proactively seek out and finance nascent technologies that could help solve some of the main technical and scientific hurdles facing AIDS vaccine research and ultimately lead to the development of more promising candidates for human testing. With an initial three-year commitment of US$10 million, half of which will be financed by a US$5 million grant to IAVI from the Bill & Melinda Gates Foundation, the Innovation Fund will provide rapid and flexible funding in just eight weeks from application to award for pioneering ideas outside the traditional realm of AIDS vaccine research.

“Now more than ever, the AIDS vaccine field needs out-of-the-box concepts that can help us develop better candidates for testing,” said Dr. Seth Berkley, IAVI President and CEO. “VaxDesign’s novel technology is one of many hidden gems that we plan to seek out and develop for AIDS vaccine research.”

"The Gates Foundation is proud to support IAVI in exploring innovative approaches for addressing the challenges of discovering an effective HIV vaccine," said Dr. José Esparza, Senior Advisor on HIV Vaccines for the Gates Foundation. "IAVI and its partners have a track record of advancing novel vaccine technologies, and of moving promising concepts rapidly into development."

The Innovation Fund is the latest addition to IAVI’s extensive research and development infrastructure, which includes a network of labs worldwide, three consortia comprised of leading AIDS researchers and a network of state-of-the-art clinical trial sites. Since its founding 11 years ago, IAVI has introduced a series of pioneering approaches to AIDS vaccine development. In the last six years alone, IAVI has translated innovative technologies into six vaccine candidates that have entered human trials in 11 countries in Asia, Africa, Europe and North America. IAVI’s Innovation Fund aims to foster a much-needed breakthrough in AIDS vaccine research by nurturing early-stage ideas and products from the most innovative scientists and companies from around the world, in order to help solve one of the greatest public health challenges we face today.

About IAVI The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health, The John D. Evans Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, Ireland, The Netherlands, Norway, Spain, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Bristol-Myers Squibb, Continental Airlines, Google Inc., Henry Schein, Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see www.iavi.org.

About VaxDesign Founded in 2003, VaxDesign develops, manufactures, and markets its proprietary MIMIC™ (Modular IMmmune In vitro Construct) models of the human immune system. The MIMIC technology functionally recapitulates the human immune system in an elegantly simple, fully automated format. Our technology predicts the immune reactivity and efficacy of vaccines and certain classes of drugs before they are tested in humans. This “clinical trial in a test tube” may reduce the risk and expense of human clinical trials and may someday replace animal testing for these applications. The MIMIC system has also been used to test the immunotoxicity of compounds and to determine the relative immunogenicity of biologic therapeutics. Development of the MIMIC technology was funded by DARPA under the Rapid Vaccine Assessment program.